Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT

Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT Mon, 28 Apr 2003 1. The New York Times reports that Janet Rehnquist, the Inspector General of the Department of Health and Human Services, has issued “a compliance guide for drug manufacturers” in . . . Continue reading →

Letter Submitted to New England Journal of Medicine re ARDS Investigation

The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.

The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.

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AHRP Comments: DHHS COI Guidance for Human Subject Protection

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 April 4, 2003 Tommy Thompson, Secretary Department of Health and Human Services Dockets Management Branch (HFA–305), Docket Number 02N–0475, Food and Drug Administration, 5630 Fishers . . . Continue reading →

AHRP Comments: DHHS COI Guidance for Human Subject Protection

Excerpt: Within the last two years numerous independent surveys and investigative news reports have documented systemic breach of research ethics. In October 2002, a Duke University survey of 108 U.S. medical schools revealed that medical institutions fail utterly to meet national and international standards aimed at ensuring the integrity of clinical research and the safety of human subjects. [See, Schulman KA, et al, Provisions in clinical trial agreements, New England Journal of Medicine, v. 347, no 17, Oct 24, 2002, pp 1335-1341.]

Corporate sponsors maintain control over the entire process including, research design, subject selection, data collection analysis, and corporate sponsors selectively skew the findings that are published…

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